Safety and Efficacy of Traction Robot-assisted Endoscopic Submucosal Dissection for Early Gastric Cancer

Shandong University

Status: Enrolling

Conditions: Early Gastric Cancer; Robot Surgery; Endoscopic Submucosal Dissection

Treatments: Procedure: Conventional ESD; Procedure: FASTER-assisted ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT06748352

SDU-QILU-G015

Details and patient eligibility

About

The goal of this clinical trial is to investigate whether the flexible auxiliary single-arm transluminal endoscopic robot (FASTER) system can improve the safety of the endoscopic submucosal dissection (ESD). It will also evaluate the efficacy of the system, such as whether it could reduce the procedure time and so on. The main questions it aims to answer are:

Does the use of the FASTER system reduce the number of muscular injuries, improving the safety of the ESD procedure? Does the use of the FASTER system reduce the procedure and dissection time, improving the efficacy of the ESD procedure? Researchers will compare FASTER-assisted ESD and conventional ESD to evaluate the safety and efficacy of the FASTER system.

Participants will:

Be randomly assigned to the group with ESD using the traditional procedure or to the group with ESD assisted by the FASTER system.

Keep a diary of their symptoms after the procedure. ESD has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. Adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of ESD. The FASTER system is designed to overcome this technical difficulty.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18-80.
• Patients with pathologically verified high-grade intraepithelial neoplasia (HGIN) or intramucosal carcinoma of the stomach.

Exclusion criteria

• Patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis.
• Patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery.
• Patients have a history of gastric malignancy with previous radiotherapy or operative treatment leading to changes in gastric structure.
• Patients have lesions with local recurrence after endoscopic resection.
• Patients unable to obtain informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

FASTER-assisted ESD group

Experimental group

Description:

Patients in this group undergo ESD with the assistance of the FASTER system.

Treatment:

Procedure: FASTER-assisted ESD

Conventional ESD group

Active Comparator group

Description:

Patients in this group undergo ESD following the clinically established pattern.

Treatment:

Procedure: Conventional ESD